Clinical Services

Medical writing –

• Investigator’s Brochure (IB)
• Study Protocol
• Case Report Form (CRF)
• Informed Consent Forms (ICF) and all submission package forms
• Clinical Study Report

Regulatory services –
we take care of all your study’s regulatory processes, including Institutional Review Board (IRB)/Ethical Committee (EC) and Competent Authority (CA) regulatory submissions

Clinical development –

• Feasibility and site selection
• Site contract and budget negotiations
• Study file set-up
• Establishment of Standard Operating Procedures (SOPs)

Clinical contract overview
Monitoring - we provide consistent and effective monitoring and interaction with study sites

• pre-study visits
• site initiation visits
• on-site monitoring
• site closure visits

Project Management –

• we focus on providing on-time, on-budget, quality deliverables.